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In Brief This Week: FIND, Sophia Genetics, Dante Labs, BioReference Laboratories, and More

NEW YORK – FIND announced this week a partnership with the Ministry of Health Malaysia, the Malaysian AIDS Council, the World Health Organization, and the Drugs for Neglected Diseases initiative for a hepatitis C virus self-testing impact study in Malaysia. The study will build on existing work on HIV self-testing via the online platform JOM Test and is focused on capturing patients who may be missed by facility-based testing. More than 400,000 people in Malaysia have hepatitis C, but only 1 percent have been treated, FIND said.

Genetic Technologies of Melbourne, Australia, this week reported A$99,000 ($73,000) in revenues from customers for its fiscal fourth quarter, up from A$6,000 in Q3. Revenues included A$95,000 from the firm's agreement with IBX to produce, distribute, sell, and market Genetic Technologies' COVID-19 risk tests in the US. As of June 30, Genetic Technologies had A$20.8 million in cash. Earlier this month, the company signed an agreement to acquire the brand and distribution rights for EasyDNA from BelHealth for $4 million.

Dante Labs said this week that it has acquired a new laboratory, a former Lighthouse Lab, at the Charnwood Campus in Loughborough, UK. The new lab, which will open next month, will provide up to 50,000 COVID-19 RT-PCR tests per day and deliver clinical whole-genome sequencing.

Blue Cross and Blue Shield of Kansas City filed a lawsuit against GS Labs this week in the US District Court for the Western District of Missouri, accusing the laboratory of price gouging related to COVID-19 testing. The payor said in a statement that it discovered price discrepancies and inflated reimbursement demands in bills submitted by the lab, including charging $380 for a rapid SARS-CoV-2 antigen test that retailed for less than $20. Other labs charged between $35 and $42 for the test, BCBS Kansas City said.

Fresh off its July 23 initial public offering, Sophia Genetics said this week that it has completed a previously announced $20 million private placement of 1,111,111 shares to an affiliate of GE Healthcare, with which the firm signed a letter of intent to codevelop new artificial intelligence-driven analytics and workflow technologies to improve the matching of treatments based on genetic and tumor profiles of cancer patients. IPO underwriters JP Morgan, Morgan Stanley, Cowen, and Credit Suisse hold the option to purchase as many as 1,950,000 additional shares at $18 each.

Becton Dickinson’s board of directors this week authorized a quarterly dividend of $.83 per common share, payable on Sept. 30 to holders of record on Sept. 9. The indicated annual dividend rate is $3.32 per share.

MGI said this week that it has opened the MGI Australia Demonstration Laboratory to support users in Australia and New Zealand. The lab offers researchers in Asia-Pacific access to MGI's technology including sequencing platforms, lab automation systems, and bioinformatics products, as well as technical support.

Genetron Health said this week that it has entered the priority review and approval process under the National Medical Products Administration of China for its companion diagnostic kit for avapritinib (CStone Pharmaceuticals' Ayvakit). According to the company, the test is the first companion diagnostic product developed in China to go through the NMPA’s accelerated review channel, which expedites the evaluation of qualified medical devices that are deemed urgent and necessary.

As a proprietary companion diagnostic, Genetron’s kit would be used to detect PDGFRA D842V gene mutations in gastrointestinal stromal tumor patients to guide the use of avapritinib. The test uses real-time PCR to detect gene mutations with high specificity and sensitivity. A clinical study utilizing the kit demonstrated data on par with that of Sanger sequencing, with concordance rates of over 99 percent.

Opko Health noted in its form 10-Q, filed with the US Securities and Exchange Commission this week, that its subsidiary BioReference Laboratories is discussing settlement with the US Department of Justice related to a Civil Investigative Demand from 2019. The demand, filed in November 2019, said that the DOJ was investigating whether BioReference paid unlawful remuneration to healthcare practitioners and submitted false claims to government healthcare programs from 2011 to 2019. The DOJ recently made a presentation to the lab regarding its position after talking to employees and reviewing submitted information. The company said that although it intends to “vigorously defend itself with respect to the claims,” it has begun discussing settlement with the agency.

PerkinElmer said last week that its board has declared a dividend of $.07 per share of common stock, payable on Nov. 12 to shareholders of record at the close of business on Oct. 22.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.