Exhibit 10.1 


 


 


 


 


 


 


 


 


LICENSE and DEVELOPMENT AGREEMENT


 


between


 


ColoAlert AS


 


and


 


PharmGenomics GmbH


 


 


 


 


 


 


 






    


    


    

 


License AND DEVELOPMENT
agreement


 


This license and development agreement (the ”Agreement”)
is entered into the 1st of January, 2019 between:


 


		(1)	ColoAlert AS, Trimtowers, Postboks 1063 Sandnes, Norway, company registration number 913 028 570 ("CA"), and



 


		(2)	PharmGenomics GmbH, Robert Koch Strasse 50, 55129 Mainz, Germany, company registration number HRB 41529 ("PGx")



 


in the following referred to individually as "Party"
and jointly the "Parties".


 


***


 


		1	BACKGROUND



 


CA is a diagnostic company established with the main objective to commercialize
a technology related to colorectal cancer detection ("CRC"), as further specified below.


 


CA has obtained an exclusive license for a non-invasive screening test
for CRC based detection of blood and genetic markers in stool samples (the "Genefec Test") from the Norwegian company
Norda ASA ("Norda"), pursuant to an exclusive license agreement signed 4 December 2017 by Norda and 6 December 2017 by
CA respectively (the "Norda Agreement"). The technology and knowhow related to the Genefec Test covered by the Norda
Agreement is for the purposes of this Agreement referred to as the "Genefec Technology".


 


PGx is an innovative company specializing in the development and distribution
of pharmacogenetic and human genetic diagnostic test for clinical applications. PGx has relevant the governmental accreditation for providing
diagnostic service in Germany.


 


Pursuant to the Contract Development Agreement GenoChip Genefec dated
29 August 2013 (now terminated), CA engaged PGx to assist CA in further developing the Genefec Test under the trademark and brand name
"ColoAlert Test", and further to get the ColoAlert Test validated.


 


The further development of the ColoAlert Test belonging to CA shall
for the purposes of this Agreement be referred to as the "ColoAlert Technology".


 


The ColoAlert Test consists of two kits: (a) "Stool Collection
Kit" (for patient use), and (b) a "Laboratory Kit" (for laboratory use).


 


The Parties entered into a Binding Term Sheet for Collaboration and
License Agreement dated 2 June 2015 which opened for a launch of the ColoAlert Test as a lab-service provided by PGx.


 


The Parties entered into a Head of Terms dated 6 May 2016 which redefined
the agreement to manufacturing and distribution of the Laboratory Kit in Europe and Gulf Cooperation Council states (the "HOT
I-agreement").


 


The HOT I-agreement was replaced by the Heads of Terms of Development
and a License for Manufacturing and Distribution of the ColoAlert Test Kits dated 31 May 2017 (the "HOT II-agreement").


 






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PGx wishes to sub-license the ColoAlert Test and the underlying intellectual
property and knowhow to third parties on the world market. PGx has, inter alia, been contacted by a Chinese Company that wishes
to manufacture, market and sell the ColoAlert Test in China.


 


CA is willing to grant PGx an exclusive license to the ColoAlert Test
and the underlying intellectual property and knowhow, including the right to sub-license, on the terms and conditions of this Agreement.


 


The Parties also wishes to continue to co-operate in developing and
improving the ColoAlert Technology.


 


The Parties therefore agree as follows:


 


		2	definitions



 


Unless otherwise specified in this Agreement, the terms set forth below
shall have the following meaning:


 


		a)	ColoAlertTestpanel: Panel of samples to ensure the uniform operative laboratory performance of the test, to be supplied by
PharmGenomics.



 


		b)	Diagnostic Laboratories: Laboratories authorized to perform genetic analysis.



 


		c)	Field of Use: Development and manufacturing of diagnostic tests, here under but not limited to cancer screening tests.



 


		d)	Licensed Kits: The ColoAlert Test as further specified in Appendix A, including the Stool Collection Kit and the Laboratory
Kit, developed by CA or its subcontractors.



 


		e)	Licensed Technology: All intellectual property and knowhow related to the ColoAlert Test, including the ColoAlert Technology
and the Genefec Technology, hereunder all historic and future work by CA and PGx work related to CRC diagnostic- and screening- test using
a combination of tumour markers and blood detected in stool by use of regular PCR and/or the use of CA and PGx technologies.



 


		f)	PGx Profit from Licensed Kits: The total revenue from Licensed Kits to Diagnostic Laboratories, Third Parties and Sub-Licensees,
including but not limited to revenue from sale, license fees, royalty fees or other contingent payment received thereunder (the "Total
Revenue").



 


The Total Revenue shall include revenue from sale of Licensed
Kits to PGx' internal use as Diagnostic Laboratory. The internal purchase price for PGx shall be the equal to the ex-works price offered
to Diagnostic Laboratories in Germany or in case of no such, the average of the ex-works obtained from Third Parties in Europe.


 


The
following costs shall be subtracted from the Total Revenue, provided that the costs are duly documented by PGx, and directly related
to Licensed Kits :


 


		●	The
                                            Protection Fee (as specified in Clause 6 below).



 


		●	Costs
                                            of sales (commission, packaging, travel & transport costs, share of personnel cost directly
                                            associated with the sale and sublicensing ColoAlert kits).



 






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		●	Costs of goods (reagents, consumables, potential licence costs to suppliers etc).



 


		●	Cost of direct production (personnel, manufacturing cost, but not administrative- and overhead- cost).



 


No margins shall be added to cost of goods and cost of direct
production. Neither shall PGx' revenue and production cost from the clinical genetic analysis be included. Neither shall there be any
deduction in the royalties, license fees or other contingent payment made by Sub-Licensees to PGx with the exception of the Protection
Fee, unless otherwise expressly agreed between the Parties in writing.


 


		g)	Sub-Licensee: Any Diagnostic Laboratories, Third Parties or other companies which have entered into a license agreement with
PGx for the manufacturing, marketing and/or sale of the Licensed Kits and/or the Licensed Technology.



 


		h)	Territory: The world.



 


		i)	Third Parties: Entities active in distribution and sale of diagnostic/screening tests to private individuals, such as providers
of Health Insurance Hospitals, Health Clinics, Pharmacies and General Practitioners.



 


		3	subject matter and scope of the license



 


CA hereby grants to PGx an exclusive license to the Licensed Technology
in the Field of Use to manufacture and sell Licensed Kits to Diagnostic Laboratories and Third Parties in the Territory and to further
develop the Licensed Technology in co-operation with CA.


 


The license shall include the right for PGx to sub-license its rights
hereunder to the Licensed Kits to Sub-Licensees on the terms and conditions set forth in this Agreement. In the event of a sub-license
PGx shall remain fully liable for all of its obligations under this Agreement.


 


PGx shall actively keep CA informed about negotiations and potential
agreements with any Sub-Licensee. Each potential agreement with any Sub-Licensee shall be subject to CA's prior acceptance in writing,
which may not be unreasonable withheld.


 


CA will neither itself nor enable other parties to be active in the
Territory for the duration of this Agreement.


 


		4	further obligations for pgx



 


PGx agrees to use its best efforts to engage in and promote the production
and sale of the Licensed Kits in the Territory.


 


PGx acknowledges and agrees that the Licensed Technology and the Licensed
Kits contains valuable intellectual property and knowhow which shall be considered CA's trade secrets and protected information, see also
Clause 13 below, and that certain information pertaining to the Licensed Technology and Licensed Kits as specified below in Clause 5 shall
not be communicated and/or forwarded to Sub-Licensees or any other Third Parties under any circumstances.


 






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		5	agreements with suB-licensees



 


PGx shall have the right to enter into agreements with Sub-Licensees
regarding the manufacturing, marketing and sale of the Licensed Kits. PGx shall not grant any Sub-Licensees more extensive or wider rights
than conferred to PGx pursuant to this Agreement.


 


Sub-Licensees may be granted the right to manufacture the Licensed
Kits subject to CA's written approval, provided that the following procedures shall be complied with:


 


		1.	All changes test of reagents, consumables, analytical setup (machines) and standard operating procedures ("SOPs")
shall be qualified, using the ColoAlert Testpanels. A test report shall be approved in writing by PGx – after consultation with
CA – before any changes are used for real patient samples.



 


		2.	The ColoAlert confidential reagents (the "ColoAlert Mix") shall consist of :



 


		a.	K-1 (K-ras primer set and probes) and K-2 (Blocker)



 


		b.	B-1 (B-ras primer set and probes) and B- 2 (Blocker)



 


		c.	H (Human DNA primer set and probes)



 


 


not be supplied from any other source than PGx:


 


The ColoAlert Mixes and the ColoAlert Testpanel shall be manufactured
exclusively by PGx and be sold under the brand name ColoAlert.


 


Sub-Licensees shall be subject to a non-compete clause obligating the
Sub-Licensee, any affiliates, legal representatives, directors and employees to refrain from developing, manufacturing and selling tests
within the field of CRC-stool for a period of 3 years after the termination of the agreement with PGx.


 


Sub-Licensees shall be subject to confidentiality obligations at least
as strict as those imposed on PGx pursuant to this Agreement, including the obligations set forth in Clause 13 below. Sub-Licensees shall
ensure that its affiliates, legal representatives, directors and employees are adequately restricted from disclosure of confidential information.


 


PGx and CA shall have the right to inspect the Sub-Licensees facilities
related to the production, marketing and sale of the Licensed Kits. PGx and CA shall also have to right to instruct the Sub-Licensees
to get the Sub-Licensees production of Licensed Kits in accordance with quality requirements and procedures set forth by PGx and CA. Sub-Licensees
shall be obliged to comply with PGx' and CA's instructions. Any Agreements between PGx and Sub-Licensees shall include the obligations
put on PGx and the Sub-Licensees pursuant to this Agreement.


 


		6	financial terms



 


PGx shall pay to CA (i) the following, as further specified in this
Clause:


 


		(i)	A protection fee (the "Protection Fee"); and



 


		(ii)	A performance based "Profit split to CA" on a quarterly basis, 15 days after every ended quarter (the "Profit Split")



 


Protection fee: The Protection Fee shall be EUR 3 per sample
analysed. The Protection fee shall be calculated from Laboratory Kits sold, meaning EUR 3 multiplied with the number of analysis which
can be performed from one Laboratory Kit sold.


 






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The Profit Split: The Profit Split shall be 50% of PGx Profit
from the Licensed Kits.


 


PGx shall at the end of each calendar quarter present a report to CA
stating and documenting the amount of Laboratory Kits sold and the PGx Profit from the Licensed Kits.


 


Payment shall be made within 30 days from receipt of invoice, if not
otherwise specified in the invoice.


 


Payment shall be made in EUR at the official rate of exchange as of
the date of payment.


 


		7	books and records



 


PGx shall keep complete and accurate books and records in accordance
with established accounting principles in sufficient detail to permit ready computation of the Protection Fee and the Profit Split payments
required under this Agreement.


 


The said records shall be open to inspection following a reasonable
notice at any time during regular business hours at the office of PGx by an independent chartered accountant of CA’s choice and
reasonably acceptable to PGx with written authority of CA, all at the expense of CA.


 


In the event that the agent or representative reports that PGx has
underpaid the amounts due to CA by more than 10 (ten) percent, PGx shall bear the cost of such audit.


 


		8	infringements



 


	8.1	Infringement challenges by third parties



 


PGx shall, at its own discretion, take reasonable steps to prevent
and prosecute third party infringement of the ColoAlert Test, and shall be responsible for all costs and expenses related hereto.


 


If either Party have knowledge of or suspect an infringement of any
of the ColoAlert Test, that Party shall promptly notify the other Party in writing thereof. CA shall have the right to request information
whether and how PGx plans to prosecute the infringing party.


 


In the event PGx fails, or decides not to commence enforcement proceedings
against the infringement, CA shall have the right, but not the obligation, to commence enforcement proceedings at its own expense.


 


		8.2	Infringement of Third Party Rights



 


PGx shall at its own cost diligently defend any claim of infringement
asserted by a third party to flow from PGx' practice of its licensed rights under this Agreement. Without limiting the foregoing, PGx
shall retain qualified litigation counsel and shall instruct said counsel to diligently defend. PGx shall keep CA fully informed of all
developments of the case.


 


CA shall at all times have the right, at its sole discretion and at
its own cost, to participate in the defence, including, but not limited to, participation in all defence strategy discussions, access
to all defence documents and materials and all technical evaluation.


 






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In no event shall PGx be entitled to enter into a settlement with a
third party without prior consultation with and approval of CA. CA may only withhold its consent if, in the opinion of CA, the proposed
settlement is not based on a bona fide and arms length basis or otherwise is detrimental to the interest of CA.


 


		9	warranty



 


CA warrants that it has entered into an exclusive license agreement
with Norda related to the Genefec Technology on the terms and conditions set forth in the Norda Agreement as attached in Appendix B.


 


To the best of CA's knowledge the development, manufacture and use
of Licensed Technology and Licenced Kits does not infringe intellectual property rights or misappropriate trade secrets of any third party.


 


Each Party warrants and represents that it has the full power, authority
and legal right to enter into this Agreement.


 


Each Party warrants and represents that it has valid and sufficient
agreements with its employees and any third parties performing work or services on behalf of that Party pursuant to the Agreement to ensure
the said employees and third parties are bound by confidentiality requirements at least as restrictive as those in the Agreement.


 


Each Party warrants and represents that it is not, and will not be
as long as this Agreement is effective, a party to any other agreement which would prevent the Party from entering into the Agreement.


 


		10	indemnities



 


CA undertakes no responsibility for the risks of industrial realisation
and commercial exploitation of the Licensed Kits which are or may be manufactured or sold by PGx or its Sub-Licensees, if any.


 


CA shall in no event be liable for any infringement of any patent rights
or other intellectual property rights of a third party due to the activities of PGx or its Sub-Licensees. If CA during the term of the
Agreement shall be held liable by a court of competent jurisdiction for infringement of any patent rights or other intellectual property
rights of a third party following from such activities, or if CA settles allegations of such infringement, PGx shall indemnify CA for
any and all costs incurred in the defence against such allegations, damages and other monies payable by reason thereof.


 


PGx shall assume full responsibility for its use of the Licensed Kits
and shall defend, indemnify and hold CA harmless from and against all liability, costs, demands, damages, expenses (including attorney's
and expert witness fees and expenses) and losses by reason of death, personal injury, illness or property damage, or any other injury
or damage arising out of the use by PGx or its Sub-Licensees of the Licensed Kits, including but not limited to, the use or reliance upon
such Products by third party customers. CA shall have no product liability.


 


PGx shall indemnify and hold CA harmless for any and all losses incurred
by CA due to breach of the confidentiality or non-compete clauses in this Agreement, including breach by its affiliates, legal representatives,
directors or employees.


 


In no event shall CA be liable to the other for any special, indirect,
exemplary or consequential damages arising out of this Agreement or use of the Licensed Kits.


 






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		11	insurance



 


Each Party shall carry and maintain such minimum insurance coverage
as required by local law, and shall each maintain insurance at its own cost necessary to cover liabilities assumed under this Agreement.


 


		12	development of the coloaltert technology, intellectual property



 


		12.1	Further development – roles and responsibilities



 


Technology Development: The Parties wish to continue co-operating
to further develop CA's proprietary owned ColoAlert Technology and the Licensed Kits. The work is to be based on an "open book"
were new ideas for improvements of methods, instruments, reagents, analytical protocols, suppliers and test results shall be shared between
the Parties. CA and PGx shall use their best efforts to finalize the development of the Licensed Kits, including choice of scientific
methods, procedures, chemicals, reagents, sample collection materials, markers, tubes, instruments and analytical markers. CA shall approve
final SOPs for external use.


 


CE-IVD approval: PGx shall be responsible for the validation
and approval of the Licensed Kits and SOPs used in PGx' lab and for external use. CA shall be listed as holder and owner of any validations
and approvals related to the Licensed Kits.


 


Sale and Distribution: CA and PGx shall jointly be responsible
for the sale and distribution of the Licensed Kits from PGx to Diagnostic Laboratories and Third Parties in the Territory. The Licensed
Kits shall be marketed and sold under the "ColoAlert" trademark and brand name if not otherwise agreed between the Parties in
writing.


 


		12.2	Costs of development and approvals



 


Each Party shall
be responsible for its own cost related to the further development of the ColoAlert Technology and CE-IVD approval (when needed) and cost
of sales of the Licensed Kits, unless otherwise agreed in writing between the PartiesCollaboration committee


 


The Parties shall form a collaboration committee with a responsibility
to monitor the development of the ColoAlert Technology and the commercialization of said technology on a monthly basis.


 


		12.3	Outsourcing



 


In the event that alternative production of the ColoAlert Test with
a lower cost base than PGx can be found and utilized, without compromising the intellectual property of CA and PGx, the Parties shall
cooperate in the process of outsourcing the manufacturing to such party. This Clause shall only come into use in the case a higher joint
profit to the Parties can documented and otherwise no other Clause in this Agreement are affected. Any agreement regarding outsourcing
of manufacturing of the ColoAlert Test shall be subject to written approval from CA, which may be withheld at CA's sole discretion.


 


		12.4	Intellectual property



 


Title and ownership to any and all existing and future intellectual
property and know how related to the ColoAlert Technology shall belong to CA. This includes all patents, trademarks, trade names, know-how,
trade secrets, technology and other intellectual property rights related to the ColoAlert Technology (the "Intellectual Property").


 


The Intellectual Property shall include the right to the ColoAlert
trademark and brand name.


 


If any of PGx' background intellectual property – meaning intellectual
property which have been developed by PGx prior to the start of the collaboration with CA – has been or will be incorporated in
the ColoAlert Technology, then CA shall be granted a perpetual, worldwide, royalty-free, non-exclusive license to use the background intellectual
property in the further use, marketing, sale and further development of its products and services; including sublicensing. The license
shall include the right to make modifications and changes to said background intellectual property.


 






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		12.5	Patent filing and patent maintenance



 


The Parties shall inform each other about any patentable invention
relating to the Licensed Technology, and take the necessary precautions to ensure the patentability of said inventions. CA shall be listed
as owner and holder of any patents and/or patent applications related to the Licensed Technology.


 


		13	confidentiality



 


All information related to the Licensed Technology and Licensed Kits
shall be considered confidential information ("Confidential Information"), unless otherwise explicitly agreed between
the Parties in writing. PGx agrees that the Confidential Information (a) shall not be used except in connection with the activities contemplated
under and during the term of this Agreement, (b) in accordance with the provisions of this Agreement, and (c) shall be maintained in confidence
by PGx.


 


The terms and conditions of this Agreement shall be deemed Confidential
Information as well.


 


The following information shall not be regarded as Confidential Information:


 


		(i)	information which was generally known by the general public or other persons within the relevant industries at the time of disclosure
other than as a result of a disclosure made in breach of this Agreement.



 


		(ii)	information which is publicised by a Party pursuant to a regulatory disclosure obligation;



 


		(iii)	information which the receiving Party acquires on a non-confidential basis from a third party, provided that such source is not prohibited
from transmitting the information to the receiving Party by any contractual or other legal obligation.



 


		(iv)	information which the relevant Party can show has been developed or compiled independently and without the aid, application or use
of the Confidential Information. 



 


PGx shall only permit access to Confidential Information to those of
its employees having a need to know and who are bound by obligations of confidentiality the same as or substantially similar to those
contained within these terms and conditions.


 


		14	non-compete



 


PGx, including its affiliates, legal representatives, directors and
employees, shall refrain from developing, manufacturing and selling tests within the field of CRC stool-testing for a period of 3 years
after the termination of this Agreement.


 






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		15	term and termination



 


This Agreement shall commence upon the signing of this Agreement by
the duly authorized representatives of the Parties and shall continue thereafter unless terminated in accordance with this Clause.


 


Either Party shall have the right to terminate this Agreement with
immediate effect by notice in writing to the other Party in any of the following events:


 


		a)	in the event a Party commits a material breach of the terms and conditions in this Agreement and does not cure said breach within
a period of 30 days after been requested to do so by the non-defaulting Party; or



 


		b)	if the other Party enters into liquidation whether compulsory or voluntarily, other than for the purpose of amalgamation or reconstruction,
or a petition in bankruptcy is filed by or against either Party in any competent court and the same is not dismissed within 60 days; or



 


		c)	either Party is adjudicated bankrupt or insolvent.



 


CA shall have the right to terminate this Agreement in the event that
the quarterly Profit Split is less than EUR 25,000. PGx shall for a period of 2 years  have
the right to maintain the License by paying the shortfall of minimum Profit Split.


 


In the event CA decides to sell ColoAlert assets (intellectual property
and know how related to the ColoAlert Test) to a party who has no interest in a continuation of this Agreement, CA shall have the right
to terminate this Agreement by giving PGx a 30 days written notice. In such event CA shall pay PGx a compensation equal to 25 % of the
net proceeds from such a transaction. PGx shall in case of a legally binding formal bid, within 60 days have a first right of refusal
to the transaction on equal terms, whereby the 25 % compensation shall be deducted from the transaction price.


 


The rights and obligations of the Parties intended by their nature
to survive termination of the Agreement are including but not limited to Clause 4 ("Further obligations for PGx"), Clause 5
("Agreements with Sub-Licensees"), Clause 6 ("Financial Terms"), Clause 7 ("Books and Records", Clause 9
("Warranties "), Clause 10 ("Indemnities"), Clause 11 ("Insurance"), Clause 12.4 ("Intellectual Property"),
Clause 13 ("Confidentiality"), Clause 14 ("Non-compete"), Clause 16 ("Assignment"), Clause 17 ("Miscellaneous")
and Clause 18 ("Governing law and dispute resolution").


 


Upon termination of this Agreement by any reason whatsoever, the Parties
shall disclose all relevant documentation and information relating to the ColoAlert Technology to the other Party.


 


Upon termination of this Agreement by any reason whatsoever, PGx shall
immediately cease any use of the trade mark and brand name "ColoAlert" and transfer to CA all rights and title to any "ColoAlert"
trademark. PGx shall assist ColoAlert to get any trademark authorities to change the owner of any "ColoAlert" trademark from
PGx to CA.


 


Upon termination of this Agreement by any reason whatsoever, PGx shall
immediately cease any use of the Genefec Technology.


 


		16	assignment



 


CA shall have the right to assign this Agreement en bloc to a company
merging with CA or acquiring a majority of the shares of CA or a substantial part of CA's business operation, hereunder the rights to
the Licensed Technology.


 






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		17	miscellanous



 


		17.1	Waiver and Modification



 


Failure by either party to enforce any provision of this Agreement
shall not be deemed a waiver of future enforcement of that or any other provision. Any waiver, amendment or other modification of any
provision of this Agreement shall be effective only if in writing and signed by the parties.


 


		17.2	Severability



 


If for any reason a court of competent jurisdiction finds any provision
of this Agreement to be unenforceable, that provision of the Agreement shall be enforced to the maximum extent permissible so as to effect
the intent of the parties, and the remainder of this Agreement shall continue in full force and effect.


 


		17.3	Changes



 


No addition or modification to this Agreement shall be valid unless
made in writing and signed by the authorized representatives of the Parties.


 


		18	governing law and dispute resolution



 


All disputes, controversies and differences which may arise between
the Parties shall be tried to be settled amicably through mutual consultation within 30 days of a written settlement request of either
Party.


 


Both Parties will use their best endeavours to settle all matters in
the dispute amicably. All disputes and differences of any kind related to this Agreement, which cannot be settled amicably by the Parties,
shall be referred to arbitration.


 


The arbitration, including appointment of arbitrators, shall be carried
out in accordance with the Norwegian Arbitration Act of 14 May 2004 (as amended) and in accordance with the principles set out herein.
The arbitration shall take place in Bergen and be conducted in the English language.


 


* * *


 


This Agreement has been prepared in 2 originals, of which each Party
has received one.


 


	ColoAlert AS	 	PharmGenomics GmbH
	 	 	 
	 	 	 
	Dagfinn Øgreid	 	Moritz Eidens



 


		Attachments:	



 


	Appendix A:	Description of the ColoAlert
test for detection of CRC.



 


	Appendix B:	The exclusive
license agreement between Norda ASA and ColoAlert AS signed on 4 and 6 December 2017 respectively.



 









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Appendix A


 


Description of the ColoAlert method for detection of CRC.


 


ColoAlert is a stool based test used for detection of colorectal cancer.
The test will combine the use of genetic markers and detection of blood in stool samples. The test is based on extracting DNA from stool
samples, and then analyzing that DNA for human DNA and somatic mutations within genes known to cause colorectal cancer. In addition, the
ColoAlert method will combine the genetic testing with established methods for measuring the presence of blood in stool samples.


 


The ColoAlert technology licensed will include two kits:


 


		-	A stool collection kit



		-	A laboratory kit for detection of CRC



 


Stool collection kit


 


This first kit will be a stool sample collection kit. It will be a
small box with the necessary tools and reagents for a patient to collect a stool sample and then deliver that sample to the ColoAlert
analysis laboratory. Each stool collection kit will contain a transport safety tube, a stool collection tube, instructions for use, and
if wanted by Third Party a packaging, transports solution and iFOBT or FOBT test may be included. More specifically, the stool collection
tube will contain a special stool transport buffer for stabilizing the DNA in the stool sample until it arrives in the laboratory. The
tube has a screw cap with a spoon attached – this spoon is used to collect the necessary amount of stool.


 


The content of the stool collection kit may be changed in the future
for improving the collection kit (e.g. new stabilizing buffer, new stool collection device etc). These possible changes should be regarded
as part of the stool collection kit and be included in the license.


 


Laboratory kit


 


This second “kit” contains the tools and reagents to perform
the necessary analysis of the stool samples for detection of colorectal cancer. The kit enables the following steps:


 


Step 1: Automated DNA isolation
from stool samples


 


The ColoAlert technology is based on extracting total DNA
from stool samples collected with the above described stool collection kit. Currently the Diasorin (NorDiag) Arrow automated nucleic acid
extraction platform is used for this purpose. There might be other DNA extraction methods developed in the future.


 


Step 2: DNA mutation analysis


 


Subsequent to the DNA isolation step, the DNA will be amplified
(copied) by means of a polymerase chain reaction (PCR) and analyzed for presence of somatic mutations in the Kras and Braf genes down
to 1%.


 


Step 3: Total Human DNA analysis


 





Subsequent to the DNA isolation step, the human DNA will
be amplified (copied) by means of a polymerase chain reaction (PCR). The analysis measures the presence of total human DNA using a realtime
PCR method to score the patient as positive or negative using a predefined threshold value.


 


Step 4: Detection of blood in stool
(if this part of the is performed in a lab and not by the physician himself)


 





If wanted by Third Parties also stool samples will be analyzed
for the presence of blood using a guaiac based FOBT test called ColoScreen from Helena laboratories. This is the same FOBT test that
was used originally in the Leipzig trial. In future versions of the ColoAlert kit this FOBT analysis may be changed with other analysis
methods for detection of blood in stool.


 


 


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